Hepatic ImpairmentPhase 1NCT04631575

An Investigational Study of SHR6390 in Participants With Mild to Moderate Liver Impairment and Healthy Participants

A Phase 1 study testing SHR6390 in people with Hepatic Impairment and Healthy Participants, run by Jiangsu HengRui Medicine Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to investigate SHR6390 in participants with different levels of liver function Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Impairment, Healthy Participants
What is being tested?: SHR6390
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Dec 2020to Mar 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

-
Participants with mild to moderate liver impairment must meet all of the following criteria to enter the study:
The informed consent is signed before the trial, and the content, process and possible adverse reactions are fully understood; Be able to complete the study according to the requirements of the test scheme;
Both male and female, subjects aged 18 to 65 years (including both ends) on the date of signing informed consent;
The body weight of male subjects is ≥50 kg, while female subjects is ≥45 kg. Body mass index (BMI) is in the range of 18.5 kg/m2-30 kg/m2;
Chronic stable primary liver disease is necessary for patients with liver impairment, then patients with Grade-A/mild liver impairment (Child-Pugh score: 5-6) and Grade-B/moderate liver impairment (Child-Pugh score: 7-6) are assessed according to Child-Pugh classification;

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Provide documentary evidence of confirmed liver impairment;
Patients who have stable medication regimen for liver impairment, complications and other concomitant diseases within at least 28 days before taking the experimental drug, and the medication does not need to be adjusted (including drug type, dosage or frequency) during the clinical trials; or those who do not use the drug;
The function of vital organs meets the following criteria: Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L (1000 / mm3); Platelet ≥ 75.0 × 109 / L (75000 / mm3); Hemoglobin (Hgb) ≥ 9.0 g / dL (90g / L); ALT and AST ≤ 5ULN; Creatinine clearance rate (CLcr) ≥ 60 mL / min; The corrected QTc interval (QTcF) ≤ 450 msec (male), ≤ 470 msec (female);
In addition to liver impairment and complications, the investigator judged good condition according to the history inquiry, vital signs, physical examination, routine laboratory examination, 12-lead ECG, EEG, etc., and there was no other clinically significant abnormality;
No family planning during the trial and within 6 months after the last administration of the trial drug, and voluntarily take effective contraceptive measures; Serum pregnancy test must be negative within 7 days before the experimental drug for women of childbearing age.

Who cannot join

-
Participants with mild to moderate liver impairment who meet any of the following criteria will not be eligible for this study:
Subjects had any of the following conditions: drug-induced liver injury; history of liver transplantation; liver failure, or cirrhosis with grade 3/4 hepatic encephalopathy, esophageal and gastric varices bleeding and other complications considered inappropriate by researchers; severe / advanced peritoneal effusion or pleural effusion requiring puncture drainage and albumin supplement; patients with hepatorenal syndrome; patients with hepatorenal syndrome;
Biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that affect bile excretion;
Patients with severe portal hypertension or previous portosystemic shunt, including transjugular intrahepatic portosystemic shunt;
In addition to primary liver diseases, those who had previously suffered from serious primary diseases of other important organs were not suitable for the trial according to the judgment of the researchers;

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Any of the following conditions occurred within 6 months prior to the study: Myocardial infarction, severe / unstable angina, symptomatic congestive heart failure (NYHA class II-IV), supraventricular or ventricular arrhythmias;
History of malignant tumor in the past 5 years;
Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
History of drug use, or have a history of drug abuse in the past five years, or have a positive drug screening (except those with drug screening positive due to concomitant drug use);
HIVAb positive, syphilisAb positive;
Pregnant or lactating women;
Strong inducers or inhibitors of CYP3A4, CYP2C9 or CYP2C8 were taken within 14 days before administration of the study drug; used traditional Chinese medicine, dietary supplements and vitamins;
Subjects with other factors not suitable to participate in this study were considered by the investigator.

About this study

Official title: A Single Dose, Open-label, Parallel Controlled Pharmacokinetic Study of SHR6390 in Participants With Mild to Moderate Liver Impairment and Healthy Participants

The purpose of this study is to investigate SHR6390 in participants with different levels of liver function

Conditions: Hepatic Impairment, Healthy Participants
Being tested: SHR6390

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR6390Drug
SHR6390, PO,single-dose

Study groups in NCT04631575
Study group	Role	What they receive
Healthy participants	Experimental	Intervention: Drug: SHR6390 single dose Receives: Drug: SHR6390
Mild liver impairment	Experimental	Intervention: Drug: SHR6390 single dose Receives: Drug: SHR6390
Moderate liver impairment	Experimental	Intervention: Drug: SHR6390 single dose Receives: Drug: SHR6390

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Maximum concentration
Measured: Day1~Day9
AUC0-t
Area under the concentration time curve from time zero to time t
Measured: Day1~Day9
AUC0-∞
Area under the concentration time curve extrapolated to infinity
Measured: Day1~Day9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2020Mar 2021

First posted17 Nov 2020
Study startDec 2020 (estimated)
Primary completionMar 2021 (estimated)
Study completionMar 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04631575
Sponsor's protocol ID: SHR6390-I-109
Status last verified: Nov 2020
First submitted: 13 Nov 2020
Last updated: 17 Nov 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hepatic Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose, Open-label, Parallel Controlled Pharmacokinetic Study of SHR6390 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
ClinicalTrials.gov ID: NCT04631575
Acronym / sponsor ID: SHR6390-I-109
Conditions: Hepatic Impairment, Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (estimated)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2020 (estimated)
Primary completion: Mar 2021 (estimated)
Study completion: Mar 2021 (estimated)
First posted: 17 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate SHR6390 in participants with different levels of liver function

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Healthy participants	Experimental	Drug: SHR6390Intervention: Drug: SHR6390 single dose
Mild liver impairment	Experimental	Drug: SHR6390Intervention: Drug: SHR6390 single dose
Moderate liver impairment	Experimental	Drug: SHR6390Intervention: Drug: SHR6390 single dose

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

-
Participants with mild to moderate liver impairment must meet all of the following criteria to enter the study:
The informed consent is signed before the trial, and the content, process and possible adverse reactions are fully understood; Be able to complete the study according to the requirements of the test scheme;
Both male and female, subjects aged 18 to 65 years (including both ends) on the date of signing informed consent;
The body weight of male subjects is ≥50 kg, while female subjects is ≥45 kg. Body mass index (BMI) is in the range of 18.5 kg/m2-30 kg/m2;

Key exclusion criteria (14 listed)

-
Participants with mild to moderate liver impairment who meet any of the following criteria will not be eligible for this study:
Subjects had any of the following conditions: drug-induced liver injury; history of liver transplantation; liver failure, or cirrhosis with grade 3/4 hepatic encephalopathy, esophageal and gastric varices bleeding and other complications considered inappropriate by researchers; severe / advanced peritoneal effusion or pleural effusion requiring puncture drainage and albumin supplement; patients with hepatorenal syndrome; patients with hepatorenal syndrome;
Biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that affect bile excretion;
Patients with severe portal hypertension or previous portosystemic shunt, including transjugular intrahepatic portosystemic shunt;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SHR6390SHR6390, PO,single-dose	Drug	Healthy participants, Mild liver impairment, Moderate liver impairment

Primary outcome

Cmax
Time frame: Day1~Day9
Maximum concentration
AUC0-t
Time frame: Day1~Day9
Area under the concentration time curve from time zero to time t
AUC0-∞
Time frame: Day1~Day9
Area under the concentration time curve extrapolated to infinity

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
Individual participant dataSharing planned: No

Related trials for Hepatic Impairment

Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
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RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR6390 in people with Hepatic Impairment and Healthy Participants, run by Jiangsu HengRui Medicine Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Day1~Day9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.